List of ventilator, CPAP, and BiPAP devices containing PE-PUR foam material in the breathing gas pathway

We are reviewing all ventilator, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the Australian Register of Therapeutic Goods (ARTG) to determine whether the devices incorporate harmful sound abatement foam. This action follows the identification of risks posed by a polyester-based polyurethane (PE-PUR) foam used as soundproofing material in devices supplied by Philips Electronics Australia Ltd.

We have identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway. We have requested evidence regarding the long-term safety to ensure these devices are safe for use throughout their expected service life. Although these additional devices contain PE-PUR foam material, it may not be the same material grade used in the devices supplied by Philips Electronics Australia Ltd. We are carefully reviewing each device to understand the composition of the foam used and whether it poses any safety risks over time. Each device is assessed individually to ensure it meets the relevant safety and performance requirements. 

For sponsors who have not provided additional evidence, or provided timeframes for additional studies, we have imposed conditions of inclusion (COI) on the ARTG entries to ensure the timely availability of this evidence to support their devices.

Below is the list of other devices (i.e. not supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purposes. We will update the list with current status as the review progresses. If hazards resulting in risks to health are identified for these devices, we will undertake appropriate product safety notification or recall action.

Published: Information about Philips' recall action of correcting their affected devices